FDA Expands Arexvy RSV Vaccine Approval to At-Risk Adults Aged 18-49
The FDA has expanded approval of GSK's Arexvy RSV vaccine to include adults aged 18 to 49 years at increased risk for lower respiratory tract disease, based on phase 3b trial data showing noninferior immune response.
The Food and Drug Administration (FDA) has expanded the approval of Arexvy (respiratory syncytial virus [RSV] vaccine, adjuvanted) to include prevention of lower respiratory tract disease (LRTD) caused by RSV in adults aged 18 to 49 years who are at increased risk. Prior to this approval, the vaccine had been indicated for individuals aged 60 years and older and in adults aged 50 to 59 years at increased risk of LRTD due to RSV.
Approval in younger at-risk adults was supported by data from a phase 3b open-label trial (ClinicalTrials.gov Identifier: NCT06389487) that evaluated the immune response and safety of Arexvy in this patient population. The study enrolled individuals with at least 1 of the following medical conditions: chronic obstructive pulmonary disease, asthma, cystic fibrosis, other chronic respiratory diseases (lung fibrosis, restrictive lung disease, interstitial lung disease, emphysema or bronchiectasis), chronic heart failure, pre-existing coronary artery disease, cardiac arrhythmia, diabetes, chronic kidney disease, chronic moderate to severe liver disease, and neurologic or neuromuscular conditions.
Findings showed a single dose of Arexvy elicited a noninferior immune response in this patient population when compared with immune responses observed in adults aged 60 years and older (primary endpoint). Safety and reactogenicity data were found to be consistent with previous phase 3 trial results supporting approval of the vaccine in other populations. The most common adverse reactions reported were injection site pain, myalgia, fatigue, headache, and arthralgia.
"This age expansion can help address a significant medical need for adults in the United States at higher risk of severe RSV disease due to certain underlying conditions, and help ease pressure on the health care system," said the GSK Head of Vaccines and Infectious Diseases Research and Development.
Arexvy is supplied as 2 vials that must be combined before administration: a lyophilized antigen component (powder) and an adjuvant suspension component (liquid). Following reconstitution, a 0.5mL dose should be withdrawn from the vial containing the reconstituted vaccine and administered intramuscularly.